G.E. Fluorocon 300 Imaging System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K902981 ↗

FDA Product Code

JAA

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• G.E. Mst 625/625II/Mst 1050/1050II Three Phase Gen

  Class I

  FDA 510(k) K902985 Active Cleared 19 Dec 1990

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  Class II

  FDA 510(k) K902980 Active Cleared 23 Oct 1990

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  FDA 510(k) K902791 Active Cleared 29 Oct 1990

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  FDA 510(k) K902988 Active Cleared 19 Dec 1990

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  FDA 510(k) K902989 Active Cleared 29 Oct 1990

• G.E. Dxd 325/350/350II/Dxd 525/525II Generators

  Class I

  FDA 510(k) K902986 Active Cleared 13 Feb 1991

See all devices from Electromek Diagnostic Systems, Inc. →

• What is the G.E. Fluorocon 300 Imaging System used for?

  The G.E. Fluorocon 300 Imaging System is a fluoroscopic image-intensified X-ray system used in radiology to provide real-time imaging during diagnostic and interventional procedures, as indicated by its classification under FDA regulation number 892.1650 for radiographic and fluoroscopic systems.

• Is the G.E. Fluorocon 300 Imaging System sterile or non-sterile, and is it single-use or reusable?

  The system is supplied as a non-sterile, reusable imaging system, meaning it is designed for multiple uses after appropriate cleaning and disinfection between patients, and is not provided in a sterile condition nor intended for single-use disposal.

• How was the G.E. Fluorocon 300 Imaging System cleared for market release?

  The G.E. Fluorocon 300 Imaging System received FDA 510(k) clearance under K-number K902981 on November 7, 1990, based on a determination of substantial equivalence to a legally marketed predicate device, following a traditional review pathway.